Pain relief options after Vioxx recall

Dr. Robert Burton, writing in the online magazine Salon, charges that Merck "knew there were heart risks associated with its painkiller -- but its own studies were designed to avoid finding out how serious they were. Without this requisite skepticism, we are at their mercy -- in this case, with fatal consequences. The U.S. Food and Drug Administration has linked Vioxx, since it was released in 1999, to more than 27,000 acute heart attacks and sudden cardiac deaths. What the agency didn't report was its own culpability in the debacle." In other words, the FDA has been hijacked by the drug industry and Americans are simply at the mercy of the drugmakers now.

But Vioxx should have never been approved in the first place, according to FDA's very own scientist Dr. David Graham. Vioxx (and its competitors like Celebrex, Bextra, Prexige, Arcoxia, etc.) are really not needed by most arthritis patients. In research completed by Bill H. McCarberg, Perry G. Fine, John E. Ware, and Carol Estwing Ferrans, simple heat wraps gave more relief to people with arthritic knee pain than over-the-counter drugs. The patients in the trial were simply either given Tylenol, which contains acetaminophen, or ibuprofen, or they wore a wrap with no heat or a ThermaCare Heat Wrap for eight hours a day. Those who wore the heat wrap had significant benefits in pain reduction and more flexibility compared to the others, the researchers found. (Related article: Nexium as an alternative to Vioxx)

In another study completed by the Altoona Arthritis and Osteoporosis Center, researchers found that patch therapy provides similar pain relief as oral medications for patients with osteoarthritis (OA) knee pain. The exploratory study involved a head to head comparison of applying the lidocaine patch 5% (Lidoderm) or taking celecoxib (Celebrex) 200 mg per day. (Related article: Will you take Vioxx if it comes back?)

Lidoderm (lidocaine patch 5%) is FDA-approved for the relief of pain associated with post herpetic neuralgia (PHN). Lidoderm produces an analgesic effect by the penetration of lidocaine from the patch into the epidermal and dermal layers of the skin, without loss of sensation or numbness. The Lidoderm patch should only be applied to intact skin. The most frequently reported adverse events with the Lidoderm patch are application site reactions, including erythema, edema, discoloration, burning sensation, pruritus or abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. (Related article: Safe painkiller guide after Vioxx recall)

The FDA-approved dosing for Lidoderm is up to three patches applied for up to 12 hours within a 24-hour period. Lidoderm has not been approved by the FDA for any indications other than for the relief of pain associated with PHN, and its safety and efficacy in other indications have not been established.

Due to safety concerns regarding the entire COX-II inhibitor class in the fall of 2004, the sponsor of the study, Endo Pharmaceuticals Inc., voluntarily elected to prematurely halt the study prior to reaching the original enrollment target. However an analysis of data after six weeks of treatment showed that of the patients treated in the Lidoderm group, 54% experienced a 30% or greater improvement in average daily pain intensity; (studies have reported that 30% or greater reductions in pain intensity are clinically meaningful to pain patients). In the Celebrex group, 62% experienced a 30% or greater improvement in average daily pain intensity. In addition, clinically meaningful reductions in pain were noted in both treatment groups at week 12.

Related articles

Doctors lose trust in FDA after Vioxx recall mess

Americans lose trust in FDA after recall of Vioxx

Links

Salon
Endo Pharmaceuticals
Lidoderm
Altoona Arthritis and Osteoporosis Center